Self-Regulation in Adolescents With FASD: The Efficacy of a Targeted Intervention
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|ClinicalTrials.gov Identifier: NCT02912962|
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : October 17, 2018
|First Submitted Date ICMJE||September 12, 2016|
|First Posted Date ICMJE||September 23, 2016|
|Last Update Posted Date||October 17, 2018|
|Study Start Date ICMJE||September 2016|
|Actual Primary Completion Date||May 2018 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Self-Regulation in Adolescents With FASD: The Efficacy of a Targeted Intervention|
|Official Title ICMJE||Self-Regulation in Adolescents With FASD: The Efficacy of a Targeted Intervention|
Fetal alcohol spectrum disorder (FASD) describes a collection of physical, mental, and behavioral disabilities that result from prenatal alcohol exposure (PAE). Individuals with FASD often struggle with self-regulation, or the ability to control thoughts, emotions and actions, which can lead to many long-term problematic life circumstances.
This study aims to improve self-regulation abilities in adolescents, aged 11-17, with FASD using a targeted intervention. Researchers adapted the Alert Program®, a developed intervention targeting self-regulation in children, to be appropriate for an adolescent FASD population. Participants are split into two groups: an FASD intervention group, and an FASD waitlist group. These groups are compared on a variety of measures. These measures include cognitive measures (executive functioning, response conflict, inhibitory control, etc), behavioural measures (self-regulation, adaptive behaviour, etc), and physiological measures (cortisol and sleep). The FASD intervention group will be tested at baseline and once after the intervention, and lastly after an approximately 12-week wait following the intervention. The FASD waitlist group will be tested at baseline, after a three month wait period, and again after receiving the intervention.
The investigators expect that the Alert program® will lead to significant improvements in participant's self-regulation abilities as evidenced by cognitive, behavioural, and physiological changes. Improving self-regulation in adolescents with FASD will reduce the high level of adverse outcomes experienced by adolescents with FASD, and help them have a successful transition into adulthood.
The goal of the proposed research is to determine if adolescents with Fetal Alcohol Spectrum Disorder (FASD) will have improvements in their ability to self-regulate after the implementation of a targeted intervention. The project is part of the larger NeuroDevNet renewal grant. The goals of the proposed project are to study adolescents with FASD to examine: 1) the association of measures of Executive Function (EF) and self-regulation with life adversities and adverse outcomes 2) cortisol regulation in FASD and its association with life adversity and difficulties with EF, self-regulation, sleep, and adverse outcomes 3) whether EF, self-regulation, sleep, and cortisol regulation can be improved with an intervention targeting self-regulation.
Can self-regulation among adolescents with FASD be improved with a targeted intervention? The investigators hypothesize that the participants with FASD in the modified Alert Program ® intervention will have greater improvements on cognitive, behavioral, and physiological measures of self-regulation compared to the wait-list control group.
Individuals with FASD display significant executive functioning (EF) impairments (e.g., inhibition, decision making, thinking flexibly) as well as difficulties in regulating their behavior. They are at risk for early life adversities (e.g., unstable home environment) and adverse outcomes including mental health issues, delinquency, and substance abuse. Adverse outcomes in FASD may result from EF and self-regulation impairments that have the potential to be mitigated with targeted interventions. Altered hypothalamic-pituitary-adrenal (HPA) activity, as indexed by plasma cortisol levels, is a physiological marker of self-regulation. Importantly, PAE is known to affect HPA activity and regulation. Sleep behaviors are also disrupted in FASD, which is another physiological marker of self-regulation.
Recognizing the profile of self-regulation deficits in FASD, and the functional outcomes of such impairments will equip the investigators to examine the impact of intervention efforts on self-regulation. Research on the efficacy of interventions to improve various indices of self-regulation in FASD is critical, as this may then prevent later adverse outcomes. The Alert Program® is an evidence-based intervention program that focuses on self-regulation. It is a widely-used program that demonstrated some efficacy in children with FASD with improvements on parental reports of EF, behavioural and emotional regulation, and tests of social cognition, inhibitory control and emotional problem-solving. The investigators anticipate that this intervention, which has not been studied in adolescents with FASD, will lead to improvements across a range of self-regulatory functions including cognitive, behavioral, and physiological indicators.
Participants. FASD Group: Recruitment and data collection in Alberta will occur in Dr. Rasmussen's and Pei's research lab at the Glenrose Rehabilitation Hospital (GRH) and with Dr. Oberlander in the Child and Family Research Institute at the University of British Columbia (under a separate University of British Columbia ethics application). The GRH facility consists of testing rooms, offices, and workstations. Participants who have participated in previous research studies by Drs. Pei and Rasmussen will be informed about the study by a research assistant and will be provided an information letter. Parents will then have the opportunity to discuss the study further and set up an appointment with the research assistant or they may contact the lab at a later time should they choose to participate. Eligible participants not currently involve in the investigators' studies will receive an information letter from the FASD Clinic at the GRH describing the study to all eligible participants (in the mail or when they are seen by the clinic), who will be blinded from researchers. Interested caregivers will then contact the researchers if they want to participate, and the project coordinator will book testing sessions. For all cognitive assessments, a trained Research Assistant will administer assessment measures with participants while the caregiver completes questionnaires and rating scales. For those interested participants who have recently been involved in another study, cognitive test results will be shared between studies to minimize the baseline testing time for the participants, and reduce practice effects as some measures cannot be re-administered within a short time frame. Caregivers will also complete a 45-minute training module and worksheet (~15 minutes) at baseline testing. This training module will provide an overview of the program as well as discuss the five categories (mouth, move, touch, look and listen) that will form the base of the intervention strategies for their teen. An RA trained in the intervention who has access to Occupational Therapy consult will be conducting the interventions.
Study Design: All participants with FASD will be tested on the assessment battery at Baseline (Time 0) which will provide important information on the profile of self-regulation impairments in FASD, as well as baseline data against which efficacy of the intervention can be evaluated. The FASD group will then be divided into the targeted intervention group (Group A) and a waitlist control group (Group B) and both groups will be tested on the battery of tests after the intervention. The waitlist group will be tested once more after a waiting period, but before they receive the intervention. This mixed design allows the investigators to control for change due to development, practice effects, regression to the mean, and familiarity with the procedures. Rolling recruitment is required so that interventions are not all running at the same time, ensuring sufficient staff and resources to administer the interventions. The investigators feel it is important to provide the intervention to all participants using a waitlist design in a timely manner for ethical and clinical reasons.
The Alert Program® will be administered individually to participants by a trained RA or occupational therapist (e.g. post-doctoral fellow or a graduate student in Psychology or Occupational Therapy) in the investigators' lab space. A different RA will conduct all post intervention testing. Baseline testing will be conducted by the interventionist RA in order to establish a rapport and gain clinical knowledge to plan and individualize sessions to meet participants needs. The intervention is based on a teen adaptation of the Alert Program developed by Therapy Works Inc modified by the research team to meet the needs of adolescents with FASD. The intervention will consist of 12 one hour sessions that take place over the course of 9-15 weeks. Over the course of the 12 sessions the participants will work on moving through 3 stages (stage 1 - identifying engine speeds, stage 2- learning strategies to change engine levels, stage 3 - regulating engine speeds).
Measures: The investigators will be using a number of different measures for pre and post analysis of behavioural, cognitive, and physiological changes. The behavioural measures are: background questionnaire, Behavioural Rating Inventory of Executive Function (BRIEF)- 2, Monetary Choice Questionnaire, Dot-Probe Test of Attention Bias to Threat, Adolescent Self-Regulatory Inventory (ASRI), Adaptive Behaviour Rating System (ABAS)-2, Child Behavior Checklist (CBCL) (youth self-report, caregiver report), and The Stressful Urban Life Events Scale. The cognitive measures are: Wide Range Intelligence Test (WRIT), Delis-Kaplan Executive Function System (D-KEFS), Iowa Gambling Test (IGT), Whack-A-Mole Test, and the Rey Complex Figure Test. The physiological measures include both salivary cortisol and fingernail cortisol samples, and the Pediatric Sleep Questionnaire (PSQ).
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Behavioral: Self-Regulation Intervention adapted from the Alert Program ®|
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date ICMJE||August 2018|
|Actual Primary Completion Date||May 2018 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||11 Years to 17 Years (Child)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Canada|
|Removed Location Countries|
|NCT Number ICMJE||NCT02912962|
|Other Study ID Numbers ICMJE||00064830|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||University of Alberta|
|Study Sponsor ICMJE||University of Alberta|
|Investigators ICMJE||Not Provided|
|PRS Account||University of Alberta|
|Verification Date||October 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP